1.1 本试验方法描述了一种实验室方法，用于评估用作人类全关节假体支承面的材料组合的磨损性能。本试验方法的主体包含适用于所有类型假体磨损应用的一般方法，而单独的附录描述了针对每个不同磨损应用（例如，线性往复运动、球杯（“髋部类型”）磨损、分层磨损等）量身定制的特定磨损试验方法和临床验证标准。本试验方法的目的是在模拟生理条件下，对每个磨损应用中的材料进行聚合物磨损率排序。 然而，必须认识到，使用这种方法可以简化接触几何形状和磨损运动。因此，该试验方法仅代表候选材料完全磨损表征的初始阶段。 1.2 所有候选材料在用于患者临床试验之前，应使用原型假体在适当的关节模拟装置中进行测试。本测试方法中描述的测试用于快速可靠地筛选不同骨科磨损应用中的磨损性能材料组合，然后再进行更昂贵和耗时的关节模拟器测试。此外，与联合模拟器试验相比，这些简化试验可用于在更实际的基础上将材料、表面光洁度或其他参数与磨损行为联系起来。 1.3 以国际单位制或英寸-磅单位表示的数值应单独视为标准值。每个系统中规定的值可能不是精确的等效值；因此，每个系统应相互独立使用。将两个系统的值合并可能会导致不符合标准。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4. 1. 本试验方法拟与平磨机或设计用于评估简化试样几何形状的类似机器上的销配合使用。 注1: 见海德尔和贝卡尔 ( 1. ) 3. 对于进行针-盘试验时的有用注意事项和潜在缺陷，解释试验结果以及低应力和高接触面积对磨损的复杂且有时相互冲突的影响。 4.2 本试验方法旨在评估材料组合与聚合物磨损量的关系，其中可量化磨损主要发生在聚合物组件上。对于某些材料组合，可能会发生对立面的严重磨损，随后会将对立面碎片颗粒嵌入聚合物中。 这种情况将导致聚合物试样的重量损失不可靠，无法作为聚合物磨损的指标。 4.3 磨损报告为聚合物试样的体积损失，作为滑动距离的函数；然而，如果由于复杂的运动模式，聚合物试样表面的滑动距离不是恒定的，则磨损可以报告为聚合物试样的体积损失，作为磨损循环的函数（在这种情况下，应定义“磨损循环”）。聚合物样品的体积损失通过将实验重量损失除以聚合物密度来确定。为便于解释，应尽可能将磨损报告为磨损循环次数和滑动距离的函数。 4.4 候选材料的比较评估参考应为符合规范的超高分子量聚乙烯（UHMWPE）的磨损率 F648 钴铬钼合金对立面轴承（符合规范要求 F75 , F799 或 F1537 )，具有修复质量表面光洁度，并用牛血清润滑（见 5.2 ).

1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material. 1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests. 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This test method is intended to be performed in conjunction with pin-on-flat wear machines or similar machines that are designed to evaluate simplified specimen geometries. Note 1: See Haider & Baykal ( 1 ) 3 for useful considerations and potential pitfalls in conducting pin on disk testing, interpreting test results and the complex and sometimes conflicting effects of lower stress and higher contact area on wear. 4.2 This test method is designed to evaluate combinations of materials with respect to the amount of polymer wear, where quantifiable wear occurs primarily on the polymeric component. With some combinations of materials, significant wear of the counterface may occur, with subsequent embedding of counterface debris particles in the polymer. Such an occurrence will render the weight loss of the polymer specimen unreliable as an indicator of the polymer wear. 4.3 Wear is reported as volume loss of the polymeric specimen as a function of sliding distance; however, if the sliding distance is not constant across the polymeric specimen surface due to complex motion patterns, wear may be reported as volume loss of the polymeric specimen as a function of wear cycles (in which case a “wear cycle” shall be defined). Volume loss of the polymer specimen is determined by dividing the experimental weight loss by the density of the polymer. For ease of interpretation, wear should be reported as a function of both the number of wear cycles and the sliding distance, when possible. 4.4 The reference for the comparative evaluation of candidate materials shall be the wear rate of ultra-high-molecular-weight polyethylene (UHMWPE) conforming to Specification F648 bearing against counterfaces of cobalt-chromium-molybdenum alloy (in accordance with Specifications F75 , F799 , or F1537 ), having prosthetic-quality surface finish and lubricated with bovine blood serum (see 5.2 ).